Kornimate/medical-research-clean huggingface dataset:
comparison of the tofscan and tetragraph during recovery of neuromuscular function in the post anesthesia care unit

Conditions: Residual Neuromuscular Blockade

Summary: the aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. the tofscan (draeger medical inc., telford, pa) represents one of the few standalone acceleromyography (amg)-based quantitative monitors available for routine clinical use in the united states. the tetragraph (senzime ab, uppsala, sweden) is a standalone electromyography (emg)-based quantitative monitor that recently received conformité européene (ce) approval. while both of these quantitative monitors can be utilized to guide intraoperative nmba re-dosing and confirm recovery, they provide their objective data via drastically different techniques.


Eligibility criteria:
inclusion criteria * age \> or = 18 years old * patients willing to participate and provide an informed consent * patients undergoing an elective surgical procedure that requires use of non-depolarizing nmba agents administered intraoperatively. exclusion criteria * patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, dupuytren contracture, or any similar wrist injury. * patients with systemic neuromuscular diseases such as myasthenia gravis * patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.

Keywords: neuromuscular blockade tofscan tetragraph amg emg
effect of triple combination of induction, concurrent and adjuvant chemotherapy in high risk nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the investigators aim to evaluate the survival benefit from triple combination of induction, concurrent and aduvant chemotherapy versus concurrent chemotherapy alone for high risk locoregionally advanced nasopharyngeal carcinoma treated with intensity-modulated radiotherapy.

all eligible patients receive intensity-modulated radiotherapy (imrt) with a total dose of 68 to 70 gy in 33 fractions to the primary tumor. patients in the experimental arm receive triple therapy of induction, concurrent and adjuvant chemotherapy. induction chemotherapy consists of docetaxel 75 mg/m², d1 and cisplatin 25 mg/m², d1-3 every 3 weeks for 2 cycles. concurrent chemotherapy in the experimental arm consists of cisplatin 25 mg/m², d1-3 every 3 weeks and xeloda 2000mg/m², d1-14 for 3 cycles. adjuvant chemotherapy consists of xeloda 2500mg/m², d1-14 for 2 cycles. concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², d1 every 3 weeks for 3 cycles.the primary endpoint is failure-free survival (ffs). secondary end points include overall survival (os), locoregional relapse-free survival (lrfs), distant metastasis-free survival (dmfs) and the incidence of grade 3 or higher acute toxicities. all efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility criteria:
inclusion criteria: * newly histologically confirmed non-keratinizing (who 1991) nasopharyngeal carcinoma. * tumor staged as t4n0-3m0 or t1-3n3m0 (the 2010 uicc/ajcc staging system). * pretreatment ebv dna ≥ 4000 copies/ml. * karnofsky scale (kps) ≥ 70. * adequate marrow: leucocyte count ≥ 4×10e9/l, hemoglobin ≥ 110g/l and platelet count ≥ 100×10e9/l. * normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) and bilirubin ≤ 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln. * adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×uln. * patients must give written informed consent. exclusion criteria: * prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * history of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume). * prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×uln), and emotional disturbance. * dihydropyrimidine dehydrogenase deficiency.
a pilot study to evaluate safety and efficacy of cigrx™ in smokers

Conditions: Smoking; Tobacco Use Disorder

Summary: a randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of cigrx™ lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke

subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.

Eligibility criteria:
inclusion criteria: * healthy adult smokers * smoking for at least 5 years * smoking at least one (1) pack of cigarettes a day exclusion criteria: * allergy to lozenge components

Keywords: dietary supplement nutraceutical
a study of rx-10045 in the treatment of dry eye disease

Conditions: Dry Eye Syndrome

Summary: the primary purpose of this study is to assess the efficacy, tolerability and safety of rx-10045 ophthalmic solution in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: 1. have a patient reported history of dry eye in both eyes 2. presence of dry eye symptoms 3. presence of dry eye signs, destabilized tear film break-up time and corneal staining exclusion criteria: 1. known contraindications or sensitivities to study medication or its components 2. any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters 3. use of disallowed medication during the period indicated prior to the enrollment or during the study 4. be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control

Keywords: rx-10045 dry eye disease
evaluation of efficacy and long-term safety for the info - instant focus © lens / pmcf

Conditions: Cataract

Summary: this is a monocentric, longitudinal, prospective, observational post-market follow-up study. 30 patients with a cataract will receive an info - instant focus © lens implant. after the cataract procedure, data collection will take place during visits planned by the physician as part of normal follow-up. patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria. the patient will be followed up after one day, one week, one month, six months, one year and three years post-op. an interim analysis will be performed with one-year clinical results. the main objective of the study is to evaluate is to evaluate efficacy and long-term safety for the info - instant focus © lens.


Eligibility criteria:
inclusion criteria: * suffering from cataract * physician has made the decision to implant on info - instant focus © lens * age ≥ 18 years, of either sex * having given written informed consent, prior to any procedure non inclusion criteria: * presenting with an astigmatism of \>1.00d * presenting contraindications for the implantation of an intraocular lens * presenting an ophthalmic disorder liable to interfere with study endpoints * history of previous intraocular surgery in the study eye in the previous 6 months * refusing or unable to comply with the follow-up schedule * participation in other interventional therapeutic trial at time of inclusion * pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation
a pilot study of effects of exenatide on body weight in non-diabetic, obese patients

Conditions: Obesity

Summary: this is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) \>= 30kg/m\^2 exclusion criteria: * have ever participated in this study previously, or any other study using exenatide (ac2993/ly2148568) or glp-1 analogs * have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry) * diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \> 3 months * have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening * used drugs for weight loss (e.g., xenical \[orlistat\], meridia \[sibutramine\], acutrim \[phenylpropanolamine\], accomplia \[rimonabant\], alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening * are actively participating in, or have participated in a formal weight loss program within the last 3 months * have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to reglan (metoclopramide) and chronic macrolide antibiotics * have been treated with any anti-diabetic medications within 3 months of screening * are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start * have had bariatric surgery * have had an organ transplant

Keywords: exenatide obesity diabetes amylin lilly
prevalence of intestinal parasitic infections in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is common medical disorder and represent a group of diseases of the gastrointestinal tract that is characterized by chronic abdominal pain , bloating , passage of mucus or straining with bowel movements, sense of incomplete evacuation after bowel movements or sense of urgency to move the bowels.several parasites including entamoeba. histolytica, giardia spp., blastocystis. hominis, and trichinella spp. have been discussed as contributing factors to the development of ibs. b. hominis is one of the most common human intestinal protozoa in both developing and developed countries. some studies have reported a significant association between the parasitic infections, especially blastocystis, and ibs.cryptosporidium has been reported in ibs patients, with the onset of gastrointestinal symptoms after an acute episode of cryptosporidiosis despite recovery and parasite clearance.numerous studies have been conducted to evaluate the association between the parasitic infections and ibs. aim of the work: to detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag.


Eligibility criteria:
inclusion criteria: * patients complaining of symptoms of ibs, such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups exclusion criteria: * patients have celiac disease, gastrointestinal malignancies , inflammatory bowel disease , hiv , and those on immunosuppression and those who had been recently taking antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks.

Keywords: irritable bowel syndrome entamoeba histolytica blastocystis hominis chronic abdominal pain diarrhea defecation constipation bloating trichinella cryptosporidium
imrt versus 3dcrt for locally advanced rectal cancer, prospective phase ii study.

Conditions: Rectal Cancer; Radiotherapy; Toxicity Due to Radiotherapy

Summary: the goal of this prospective phase ii study was to determine whether personalized planning-based ncrt for larc would indeed decrease small bowel dose, and whether selected plans, specifically prioritizing lower dose to small bowel, would result in lower rates of acute gi toxicity compared with previously reported rates.

the standard of care for locally advanced rectal cancer is neoadjuvant chemoradiotherapy. however, acute gastrointestinal (gi) toxicity is common. some retrospective studies suggested that intensity modulated radiation therapy( imrt) reduces acute bowel toxicity compere to 3d conformal radiotherapy (3dcrt).the aim of this prospective phase ii study to determine whether the use of imrt planning in neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer can decrease small bowel irradiation dose compared to commonly used 3d conformal techniques ,and the rate of acute gi toxicity. patients (pts) with clinical stage ii-iii rectal adenocarcinoma were enrolled in a prospective phase ii study of preoperative chemoradiation. for each patient two radiation plans were performed: imrt and 3dcrt. after comparing two dvh (dose volume histogram) plans for organs at risk (oars), such as small bowel and bladder, pts were treated according to the plan with maximal critical organs sparing. all patients received 45 gy in 25 fractions to the rectum and draining lymph nodes, followed by boost to the tumor, with concurrent capecitabine or 5- fluorouracil .weekly follow up was performed to assess acute toxicity. the investigators hypothesize that the use of imrt in neoadjuvant chemoradiation for locally advanced rectal cancer may reduce the small bowel and bladder irradiated volume and consequently reduce acute toxicity.

Eligibility criteria:
inclusion criteria: * patients with locally advanced rectal adenocarcinoma * performance status of 0-2 * adequate hematologic, renal, and hepatic function exclusion criteria: * prior radiotherapy to pelvis * metastatic disease at diagnosis
a trial of shr-a1921 for injection in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of shr-1921.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content 3. male or female 4. subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy 5. ecog performance status of 0-1 exclusion criteria: 1. has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites 2. has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression 3. has known history of other documented malignancy 4. has known history of acquired immunodeficiency syndrome (aids) 5. has significant cardiovascular disease that is not well controlled, such as: (1) new york heart association (nyha) grade ≥ 2 cardiac failure 6. has active or prior documented interstitial pneumonia/interstitial lung disease 7. has experienced grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose 8. has known active hepatitis b 9. has known allergies to shr-1921 component 10. has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.
atrial flutter ablation in a real world population

Conditions: Atrial Flutter

Summary: the "leonardo" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for atrial flutter isthmus-dependent (afl) ablation will be enrolled. patients can be treated with any market released catheter for ablation. the decision to perform the ablation of afl will be made based on clinical evaluation of the investigators according to their clinical practice. the study does not require specific surgical techniques. patient time commitment for the study is approximately 12 months.the study has been designed to describe the italian clinical practice in relation to the approach of afl ablation. in particular, the investigators will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers.

catheter ablation of atrial flutter has become an accepted alternative to pharmacologic therapy.the current guidelines recommend the catheter ablation at the first episode of afl (class iia) or in any case of recurrent episodes of afl (class i). recent studies have already demonstrated a high degree of procedural efficacy (higher than 90%). however, there are still two main areas of investigation. first, what is the best method to obtain an effective lesion. second, what is the most reliable method to validate the procedure success.the present study is aimed at investigating these aspects in the current italian clinical practice.

Eligibility criteria:
inclusion criteria: * patient undergoing ablation of atrial flutter isthmus-dependent * patient able to sign an authorization to use and disclose health information or an informed consent. * patient available to attend scheduled follow-up visits at the center for at least 12 months exclusion criteria: * patient is participating in another clinical study that may have an impact on the study endpoints

Keywords: cardiac catheter ablation cardiac arrhythmias atrial flutter
performance value of research of occult gastrointestinal bleeding by immunoassay in the diagnostic process of iron deficiency anemia in patients over 75 years

Conditions: Occult Gastrointestinal Bleeding

Summary: this study aims to characterize the diagnostic performance of immunological testing of occult gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency anemia. as secondary objectives, the study aims to: * determine a threshold of positivity optimizing the immunoassay performance for the study population, in accordance with the probabilities of error (false positives, false negatives) and weights (defined by expert consensus) allocated to these errors. * assess the benefit of a double measure of bleeding (two stools) by immunoassay compared to a single measure.

immunological testing will be performed systematically for each patient. research of blood in fecal sample will be based on 2 methods: one based on a qualitative immunochromatographic method (such as hemsign4 technique, servibio, france; or all other techniques used at ap-hp) and another quantitative immunoturbidimetric method (oc-sensor, eiken, japan). they will be performed systematically with two fresh fecal samples for each patient, before coloscopy examination. treating physicians will not be provided with the testing result. the diagnosis of reference will be established by experts based on the result of explorations (colonoscopy, coloscanner) and the patient's progression, blinded to the result of immunoassay. the intrinsic characteristics of the immunoassay (sensitivity, specificity...) will be determined with reference to this reference diagnosis, using a positivity threshold defined using expert consensus on the weights to be allocated to potential errors. 2 modeling scenarios (without vs with immunological testing) using decision trees based on prevalence and diagnostic performance observed and stochastic simulations.

Eligibility criteria:
inclusion criteria: * physical status score 3 or 4, aged 75 and older patient, (patients under guardianship may be included). * iron deficiency anemia (hb≤120 g/l for a woman or hb≤130 g/l for a man), and nonregenerative anemia with reticulocytes \<120 000/mm3. * patient who has indication for colonoscopy and / or colonography examination, whatever the results of gastroscopy if performed. * have a health insurance. * informed consent signed. exclusion criteria: * hematemesis or melena * life expectancy inferior to 12 months * patient has difficulty in follow-up of study.

Keywords: occult gastrointestinal bleeding iron deficiency anemia aged 75 years and older
zuojin wan combined with vonoprazan-amoxicillin dual therapy in h.pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of zuojin wan combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori associated chronic gastritis,through a randomized controlled trail.

helicobacter pylori（h.pylori）is a gastric pathogen, related to various gastrointestinal disorders. it's now a consensus of experts that h.pylori infection should be treated once it is recognized. vonoprazan and high-dose amoxicillin dual therapy is a potential h.pylori eradication regimen. it provides a satisfactory eradication rate of 90%. nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. the main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. combining traditional chinese medicine may be one of the effective ways to solve the above problems.this study aims to compare the efficacy of zuojin wan combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old 2. patients with h.pylori infection 3. diagnosed as functional dyspepsia 4. meet the diagnostic criteria of h. pylori liver-atomach stagnation heat syndrome in traditional chinese medicine. 5. patients who have not received h. pylori eradication treatment before, or who have failed eradication in the early stage but have not received eradication treatment within six months. 6. volunteer to participate in this experiment and sign the informed consent. exclusion criteria: 1. allergy to research drugs (penicillin allergy, etc.) 2. patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases. 3. patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases 4. patients who have received h. pylori eradication treatment within six months. 5. antibiotics and bismuth were used 4 weeks before the start of study treatment, and histamine h2 receptor antagonist or ppi was used 2 weeks before the start of study treatment. 6. use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants. 7. history of esophageal or gastric surgery 8. pregnant and lactating women